LASEmaR 1500
FDA 510(k) clearance K260489 · decided 2026-05-29
Clearance details
- K-number
- K260489
- Device name
- LASEmaR 1500
- Applicant
- Eufoton S.R.L.
- Decision
- Substantially Equivalent
- Date received
- 2026-02-13
- Decision date
- 2026-05-29
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- GEX
- Device class
- 2
- Regulation number
- 878.4810
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Trieste, IT
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.